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Comparative clinical efficacy and safety of immediate release and controlled release hydromorphone for chronic severe cancer pain
Author(s) -
Hays Helen,
Hagen Neil,
Thirlwell Michael,
Dhaliwal H.,
Babul Najib,
Harsanyi Zoltan,
Darke Andrew C.
Publication year - 1994
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19940915)74:6<1808::aid-cncr2820740625>3.0.co;2-y
Subject(s) - hydromorphone , medicine , cancer pain , chronic pain , cancer , anesthesia , clinical efficacy , immediate release , intensive care medicine , surgery , pharmacology , opioid , physical therapy , receptor
Background. The short elimination half‐life of hydromorphone necessitates 4‐hourly dosing to maintain optimal levels of analgesia in patients with chronic cancer pain. The purpose of this study was to compare the clinical efficacy and safety of controlled release hydromorphone administered every 12 hours and immediate release hydromorphone administered every 4 hours in patients with chronic severe cancer pain. Methods. Forty‐eight patients with stable chronic severe cancer pain were randomized, in a double‐masked crossover study, to controlled release hydromorphone every 12 hours or immediate release hydromorphone every 4 hours for 7 days each. Pain intensity was assessed using a visual analog scale (VAS) and the Present Pain Intensity Index of the McGill Pain Questionnaire. Nausea and sedation were also assessed using a VAS. Assessments were made by the patient four times a day at 7: 00 a. m., 11: 00 a. m., 3: 00 p. m., and 7: 00 p. m. Use of rescue hydromorphone also was recorded by the patient. Results. Forty‐five patients completed the study (26 women, 19 men; mean age, 57.1 ± 13.6 years) and received a mean daily dose of 76 ± 133 mg (range, 6‐768 mg). There were no significant differences between controlled release hydromorphone and immediate release hydromorphone in overall VAS pain intensity scores (19 ± 14 vs. 20 ± 14 mm), ordinal pain intensity scores (1.2 ± 0.8 vs. 1.2 ± 0.8) and pain scores by day of treatment or time of day. The daily rescue analgesic consumption during controlled release hydromorphone and immediate release hydromorphone did not differ significantly overall (1.1 ± 1.1 vs. 1.0 ± 1.1 doses per day) or with respect to time of day. There were no significant differences in overall VAS sedation scores (18 ± 18 mm vs. 19 ± 18 mm) and in overall mean VAS nausea scores (12 ± 15 mm vs. 11 ± 14 mm) between controlled release hydromorphone and immediate release hydromorphone. Conclusion. Controlled release hydromorphone administered every 12 hours is as effective as immediate release hydromorphone administered every 4 hours in the management of patients with chronic severe cancer pain. The benefits of controlled release hydromorphone lie in the convenience of its capsule formulation, which can be sprinkled on soft food, and its 12‐hour duration of action, which allows patients uninterrupted sleep and improved compliance.